Cleared Traditional

K926393 - VIDAS THYROXINE (T4) ASSAY (T4)

K926393 is the FDA 510(k) clearance for VIDAS THYROXINE (T4) ASSAY (T4) by Biomerieux Vitek, Inc.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K926393 · Biomerieux Vitek, Inc. · Chemistry device
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May 1993
Decision
143d
Days
Class 2
Risk

K926393 is an FDA 510(k) clearance for the VIDAS THYROXINE (T4) ASSAY (T4). Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on May 13, 1993 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K926393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date May 13, 1993
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 88d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 56
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K926393.
CEDIA T4 MAB ASSAY MODIFICATION
K935880 · Microgenics Corp. · Mar 1994
COBAS (R) CORE T4 EIA
K932605 · Roche Diagnostic Systems, Inc. · Jan 1994
ACCESS(R) THYROXINE ASSAY
K926475 · Bio-Rad Laboratories, Inc. · Jun 1993
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433 · Syva Co. · Sep 1992
MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
K920712 · Medix Biotech, Inc. · Mar 1992
CEDIA T4
K915194 · Boehringer Mannheim Corp. · Dec 1991